CoLumbo C-Spine
K-Number: K254015 · 2026-04-01
Device Summary
Frequently Asked Questions
What is the CoLumbo C-Spine?
CoLumbo C-Spine is a medical device that received FDA 510(k) clearance on 2026-04-01. The listed applicant is Smart Soft Healthcare AD. The 510(k) number is K254015.
When did CoLumbo C-Spine receive FDA 510(k) clearance?
CoLumbo C-Spine received FDA 510(k) clearance on 2026-04-01, under 510(k) number K254015.
Who is the listed applicant for CoLumbo C-Spine?
The FDA 510(k) record lists Smart Soft Healthcare AD as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CoLumbo C-Spine?
The FDA product code for CoLumbo C-Spine is QIH.
Other records listing Smart Soft Healthcare AD as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: QIH)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.